How to Register Medicinal Products through the Decentralized Procedure

Overview

This course, a Thomson Reuters Cortellis Regulatory Online Learning module, covers how to register a pharmaceutical or medical product using the decentralized procedure. The course examines the products the procedure applies to and describes the steps for completing and submitting a marketing authorization application. The phases and key events of the evaluation process and the possible outcomes of the procedure are discussed. The course concludes by examining the tasks that occur after the decentralized procedure is finalized and the parties responsible for completing them.

Featured Topics

Registering a pharmaceutical or medical product using the decentralized procedure

Who Should Attend

Professionals and experts in the pharmaceutical, biotechnology, and medical device fields

Learning Objectives

Participants who complete this course should be able to:

Understand to which products the decentralised procedure applies

Clarify the aspects to consider when defining a strategy for submission

Identify the authorities that can provide regulatory and/or scientific advice